Protocol summary
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Study aim
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Comparison of the effects of Rivaroxaban and Enoxaparin on the reduction of venous thromboembolism after spinal surgery
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Design
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A phase 3 Randomized clinical trial, with parallel group designed for 250 patients
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Settings and conduct
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Patients who underwent spine surgery at Imam Hossein Hospital in Tehran were included in the study to evaluate the effects of rivaroxaban and enoxaparin on reducing post operation deep vein thrombosis and venous embolism. All patients were evaluated after surgery for DVT and PTE by venous Doppler ultrasound and CT angiography of the lungs.
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Participants/Inclusion and exclusion criteria
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Patients who have undergone spine surgery and have no previous history of venous thromboembolism or cerebrovascular accident.
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Intervention groups
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Patients after spine surgery were divided into 3 groups, the group receiving Rivaroxaban, the group receiving Enoxaparin and the control group.
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Main outcome variables
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Deep vein thrombosis; Pulmonary thromboembolism
General information
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Reason for update
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Supplementary data from the clinical trial was recorded
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20200808048333N1
Registration date:
2021-10-29, 1400/08/07
Registration timing:
registered_while_recruiting
Last update:
2023-07-30, 1402/05/08
Update count:
1
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Registration date
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2021-10-29, 1400/08/07
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2020-08-22, 1399/06/01
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Expected recruitment end date
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2021-07-21, 1400/04/30
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Actual recruitment start date
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2020-08-22, 1399/06/01
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Actual recruitment end date
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2022-12-13, 1401/09/22
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Trial completion date
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empty
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Scientific title
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Evaluation of the effect of Rivaroxaban and Enoxaparin on preventing the venous thromboembolism after spinal surgery
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Public title
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Comparison of Rivaroxaban and Enoxaparin for preventing venous thromboembolism after spine surgery
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Purpose
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Prevention
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Inclusion/Exclusion criteria
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Inclusion criteria:
Patients undergoing spine surgery
No previous history of thromboembolism
Exclusion criteria:
Previous history of venous thromboembolism
Pregnancy
History of cerebrovascular accident
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Age
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From 18 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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- Participant
- Care provider
- Investigator
- Outcome assessor
- Data analyser
- Data and Safety Monitoring Board
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Sample size
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Target sample size:
200
Actual sample size reached:
220
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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the block randomization method will be used, and 11 blocks of 10 people will be created. Sealed Envelope online software will be used to create random codes. The number of patients in groups A and B in each block is equal, but the random sequence will differ.
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Blinding (investigator's opinion)
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Triple blinded
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Blinding description
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All Participants, Investigators, Outcome assessors, Data analyst, and quality controller are blinded. Due to the difference in the form of administration, the double dummy technique was used for blinding, as patients in the enoxaparin group received the injectable form of enoxaparin and placebo tablets, and the patients in the rivaroxaban group received the injectable form of placebo and rivaroxaban tablets.Placebo forms (both tablets and injectable forms) have the same shape, color and packaging as the original drug form.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2020-11-10, 1399/08/20
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Ethics committee reference number
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IR.SBMU.MSP.REC.1399.411
Health conditions studied
1
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Description of health condition studied
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Deep Venous Thrombosis And Pulmonary Eembolism
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ICD-10 code
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I82.4
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ICD-10 code description
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Acute embolism and thrombosis of deep veins of lower extremity
Primary outcomes
1
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Description
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Deep Vein Thrombosis
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Timepoint
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At the begining of the study,14 days after
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Method of measurement
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Color Doppler Ultrasonography of the lower Extremities
Intervention groups
1
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Description
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Intervention group: Recipient of Rivaroxaban, patients that receive Rivaroxaban (10mg orally) once daily after surgery to prevent venous thromboembolism, until discharged from hospital.In this group, the effects of this drug on thromboembolic events after surgery will be investigated.
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Category
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Treatment - Drugs
2
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Description
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Intervention group: Recipient of Enoxaparin, patients that recieve Enoxaparin (40 mg subcutaneous ) once daily after surgery to prevent venous thromboembolism, until discharged from hospital.In this group, the effects of this drug on thromboembolic events after surgery will be investigated.
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Category
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Treatment - Drugs
3
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Description
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Control group: no medication
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Category
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N/A
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Shahid Beheshti University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available
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Title and more details about the data/document
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All data can be shared.
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When the data will become available and for how long
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Access period starts 6 months after the publication of the study
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To whom data/document is available
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Researchers working in academic and scientific institutions
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Under which criteria data/document could be used
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For scientific and academic studies
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From where data/document is obtainable
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Contact with Shahid beheshti university of medical sciences(info@sbmu.ac.ir) and Dr.hamidreza khayat kashani (hamidkhayat@yahoo.com).
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What processes are involved for a request to access data/document
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After approval from the University Vice Chancellor for Research, it is possible to share data.
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Comments
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